Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA Clarifies the Term ‘Outsourcing Facility’ and Requirements for 503A Compounders

As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility.

Under Section 503B of the Food, Drug and Cosmetic Act, an outsourcing facility is defined as “a facility at one geographic location or address” that engages in the compounding of sterile drugs, has decided to register as an outsourcing facility and complies with all of the section’s requirements.

A facility — defined as a business or entity under one management that engages in drug compounding — may be composed of one or multiple suites inside a single building, or multiple buildings at one geographic location or address.